NeoTract’s Minimally Invasive UroLift® System for Enlarged Prostate Now Shown to be Durable Through Five Years: Results from Pivotal L.I.F.T. Randomized Study Presented
NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced five-year follow-up data from the pivotal, randomized L.I.F.T. IDE study, which evaluated the safety and effectiveness of the company’s novel UroLift® System in patients with symptomatic benign prostatic hyperplasia (BPH).
Claus Roehrborn, M.D., professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas and co-principal investigator for the L.I.F.T. clinical program, presented the results at the 18th annual European Urological Association meeting in London.
“The UroLift System is truly a new standard for the treatment of BPH. This conclusion of the landmark L.I.F.T. randomized clinical trial offers high quality clinical data that demonstrate the durable benefits this unique treatment option can offer,” said Dr. Roehrborn. “The UroLift System treatment delivers a truly minimally invasive patient experience: it can be performed efficiently and effectively under local anesthesia, typically without the need for a postoperative urinary catheter. Symptom relief is achieved rapidly, within two weeks, and at one month is very similar to what can be expected at five years. Serious side effects of traditional surgery are avoided, and the UroLift System treatment is the only procedure shown to not cause sustained sexual issues.”
“I believe that the UroLift System should be considered an early treatment option for men with BPH, given the safety and benefits of the procedure and the large number of patients for whom pharmaceutical therapy is either insufficient or intolerable due to side effects, cost or inconvenience.”
Results of the five-year L.I.F.T. study demonstrate that UroLift System treatment provides:
- A highly tolerable, minimally invasive procedural experience;
- Rapid reduction of symptoms after the procedure while preserving sexual function;
- Sustained effect, with IPSS (International Prostate Symptom Score) and Qmax (peak urinary flow rate) remaining 36% and 44% improved from baseline, respectively;
- Quality of life (QoL) score improvement of 50% over five years;
- A durable treatment with a low retreatment rate of 2-3% per year.
“This excellent long-term data reinforces our enthusiasm about the UroLift System treatment becoming the standard of care first-line treatment for men unhappy with BPH medications,” said Dave Amerson, president and CEO, NeoTract, Inc. “Adoption of the UroLift System continues to grow rapidly. We are excited to partner with urologists to help men return to normal urinary function and preserve sexual vitality with this safe and effective treatment option – the only BPH procedure that does not require cutting, heating or removal of the prostate tissue.”
Additional data from the L.I.F.T. clinical trial will be presented at the 2017 American Urological Association (AUA) conference taking place May 12-16 in Boston.
More than 37 million men in the United States are affected by BPH, which occurs with advancing age when the prostate gland that surrounds the male urethra becomes enlarged and begins to obstruct the urinary system. Symptoms of BPH often include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life.
Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts, heats or removes prostate tissue to open the blocked urethra.
About the UroLift System
The FDA-cleared UroLift System is a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The UroLift System is available in the U.S., Europe, Australia and Canada. Learn more at www.UroLift.com .
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. The company’s initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at www.NeoTract.com .
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